510(k) K162316 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Pirouette 014
| Applicant | Arravasc, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Nov 22, 2016 |
| Received | Aug 18, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162316
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.